EMERYVILLE, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2021, and provided a corporate update. The Company will host a conference call today, Thursday, November 4, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

"In the third quarter, we made significant progress against our corporate objectives in commercial operations and late-stage clinical development programs. We are pleased with the ongoing launch of FINTEPLA in the U.S. and EU and are encouraged with the positive trends that support continued adoption in Dravet syndrome. With the sNDA submitted for LGS, we are moving forward with regulatory submissions for LGS in the EU and a J-NDA in Japan for Dravet syndrome by the end of the year. We are excited to have the opportunity to potentially serve more patients who could benefit from FINTEPLA," said Stephen J. Farr, Ph.D., President and CEO of Zogenix.

"Concurrently, we are advancing our late-stage development pipeline, notably our global Phase 3 study of FINTEPLA in CDD and concluding studies of MT1621 for the treatment of Tk2 deficiency," concluded Dr. Farr.

Corporate Update

Third Quarter 2021 Financial Results

Nine Months Ended September 30, 2021 Financial Results Compared to Nine Months Ended September 30, 2020

Conference Call Details
Thursday, November 4, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Toll Free:855-327-6838
International:604-235-2082
Conference ID:10016695
Webcast:http://public.viavid.com/index.php?id=146849

About Zogenix

Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company's first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs: one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed," and similar expressions are intended to identify forward-looking statements. These statements include: the timing and ability of Zogenix to complete regulatory submission in the EU and Japan for its product candidates; the expected timing of reporting data from clinical trials; the expected timing of review of Zogenix's regulatory submissions including the sNDA for the treatment of seizures associated with LGS; Zogenix's commercialization plans in the U.S. and Europe; and Zogenix's plans with respect to its development programs. These statements are based on Zogenix's current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: FINTEPLA may not achieve broad market acceptance as a treatment option of Dravet syndrome which would limit Zogenix's ability to general revenues; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process or controlled access program;; the COVID-19 pandemic may continue to disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix's ability to generate product revenue in Europe and conduct its development programs; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit regulatory approval or commercialization, or that could result in recalls or product liability claims; later developments with FDA that may be inconsistent with the already completed meetings; additional data from Zogenix's ongoing studies may contradict or undermine the data previously reported; the potential for the FDA to delay timing of review of the sNDA due to the FDA's internal resource constraints or other reasons; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

CONTACTS:

Zogenix

corpcomms@zogenix.com

Investors

Brian Ritchie 

Managing Director, LifeSci Advisors LLC

+1 (212) 915-2578 | britchie@lifesciadvisors.com

Media

Trish McCall, Porter Novelli

+1 (805) 390-3279 | trish.mccall@porternovelli.com

ZOGENIX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

(In thousands, except par value)

  September 30, 2021 December 31, 2020
ASSETS    
Current assets:    
Cash and cash equivalents $106,138  $166,916 
Marketable securities 236,886  338,193 
Accounts receivable, net 9,486  3,824 
Inventory 3,502  1,026 
Prepaid expenses 13,950  7,279 
Other current assets 5,500  4,936 
Total current assets 375,462  522,174 
Property and equipment, net 7,593  8,724 
Operating lease right-of-use assets 6,862  7,748 
Intangible asset, net 92,644  98,558 
Goodwill 6,234  6,234 
Other non-current assets 8,192  7,692 
Total assets $496,987  $651,130 
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current liabilities:    
Accounts payable $12,113  $11,945 
Accrued and other current liabilities 46,111  54,964 
Deferred revenue, current 5,048  5,318 
Current portion of operating lease liabilities 1,654  1,688 
Current portion of contingent consideration 13,500  8,800 
Total current liabilities 78,426  82,715 
Deferred revenue, noncurrent 3,436  5,479 
Operating lease liabilities, net of current portion 9,055  10,314 
Contingent consideration, net of current portion 25,900  33,600 
Convertible senior notes 155,871  149,353 
Total liabilities 272,688  281,461 
Commitments and contingencies    
Stockholders' equity:    
Common stock and additional paid-in capital 1,721,694  1,694,580 
Accumulated deficit (1,497,370) (1,324,840)
Accumulated other comprehensive loss (25) (71)
Total stockholders' equity 224,299  369,669 
Total liabilities and stockholders' equity

 $496,987  $651,130 

ZOGENIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

(In thousands, except per share amounts)

  Three Months Ended September 30, Nine Months Ended September 30,
  2021 2020 2021 2020
Revenues:        
Net product sales $21,398  $1,520  $51,269  $1,520 
Collaboration revenue 1,212  1,340  3,813  3,621 
Total revenues 22,610  2,860  55,082  5,141 
Costs and expenses:        
Cost of product sales (excluding amortization of intangible asset) 1,294  140  3,192  140 
Research and development 33,255  34,425  100,868  102,038 
Selling, general and administrative 39,559  24,583  104,713  70,332 
Intangible asset amortization 1,972  1,971  5,914  1,971 
Acquired in-process research and development costs —  1,500  —  4,500 
Change in fair value of contingent consideration 400  1,800  1,500  6,100 
Total costs and expenses 76,480  64,419  216,187  185,081 
Loss from operations (53,870) (61,559) (161,105) (179,940)
Other income (expense), net:        
Interest income 85  934  579  2,504 
Interest expense (3,848) —  (11,373) — 
Other, net (371) 536  (631) 20,798 
Total other (expense) income, net (4,134) 1,470  (11,425) 23,302 
Loss before income taxes (58,004) (60,089) (172,530) (156,638)
Income tax benefit —  —  —  (17,425)
Net loss $(58,004) $(60,089) $(172,530) $(139,213)
         
Net loss per share, basic and diluted $(1.04) $(1.08) $(3.09) $(2.62)
         
Weighted average number of shares used in the calculation of basic and diluted net loss per common share 55,905  55,548  55,831  53,039 


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